Shire Quality Control Value Stream Manager in Lexington, Massachusetts

Primary Duties:

Responsible for coordinating aspects of the QC value stream to ensure new product introduction (NPI) deliverables are met on time and in full. Value stream includes method transfer, qualification, and validation for drug substance/drug product and raw materials. The role is a non-laboratory position working alongside the laboratory management to provide coordination and act as the key point of contact for NPI projects.

This position requires competent understanding and demonstrated experience in Quality laboratory operations, the ability to develop project plans with a team, manage performance through collaboration and influence, and identify compliant solutions to operational challenges. The individual will be expected to represent the QC laboratories at key project meetings, develop and maintain project plans using common tools/applications such as MS Project, and work with laboratory leads to identify and eliminate obstacles.

In addition, this role will participate in operational excellence initiatives, and various quality systems (deviations, change controls).

Responsibilities ​:

25-40% Project planning/development of timelines:

25-40% Project representation/updates, interfacing with laboratory lead

25-40% Laboratory support, for example quality systems and OE activities

10-20% Other – Participate in training, development, and improvement activities

Education & Experience Requirements

  • Minimum of a bachelor’s degree in a scientific discipline and 10 or more years related experience in a Biotech environment, esp. Quality Control laboratory preferred.

Demonstrated ability to develop project plans and advance to completion on time and in full

Other Requirements

Routine travel is not expected, but periodic opportunities for training and development may require limited travel.

The following physical abilities are required in order to fulfill the job duties:

  • Ability to work around chemicals as an observer only. The role is not expected to perform actual lab operations.

  • Ability to wear basic personal protective equipment such as gloves, gowning, and eye protection while in laboratory areas.

  • Ability to walk and stand for periods of time.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.